MedApp S.A. reaches new standards: MDR certification for CarnaLife Holo and CarnaLife System.

MedApp S.A., a leading pioneer in innovative AR (augmented reality) medical technology solutions, is pleased to announce that our advanced products CarnaLife Holo and CarnaLife System have been awarded the prestigious MDR (Medical Device Regulation) certification. The certificate was granted by the internationally recognised notified body TÜV NORD, confirming the highest standards of quality and safety of our medical solutions.

Receiving MDR certification is a key milestone in the continued growth of our company and a testament to our ability to meet the most stringent regulatory standards. Compared with the previous CE certification, MDR introduces significantly higher requirements for the safety, effectiveness and quality of medical devices. The process of obtaining the MDR certificate is far more complex and time-consuming, making its acquisition a remarkable achievement. MedApp S.A. is one of the few entities in Poland to have earned this certification, highlighting our leading position in the industry and our advanced approach to quality management.

Thanks to MDR certification, our products can now be placed on the European Union market with the latest applicable certification, which not only confirms their compliance with strict regulatory requirements but also supports and accelerates their sales in this market. Holding the MDR certificate also opens new and significant opportunities for international expansion. Our products can be introduced more swiftly and efficiently to markets outside the European Union, where many countries recognise MDR standards as the basis for an expedited or automatic certification process. Countries where the MDR certificate facilitates the introduction of our products include Switzerland, Norway, Iceland, Liechtenstein, Turkey, Australia, Canada, the United Arab Emirates, Saudi Arabia, Qatar and New Zealand.

Obtaining the MDR certificate not only strengthens our presence in the European market but also provides a strategic advantage on the global medical scene. It gives our clients and partners confidence that our products meet the highest standards of quality and safety, which are essential in the rapidly evolving healthcare sector.

MedApp S.A. proudly celebrates this significant milestone as a testament to our determination and commitment to delivering innovative, high-quality medical solutions. We are grateful to our employees and partners for the invaluable support that has enabled us to reach this major goal. We continue our efforts to provide solutions that contribute to better health and quality of life worldwide.